Method of Osteosyntheses or Arthrodesis of Two - Bone Parts, In Particular of The Hand and / or Foot

ABSTRACT

In one embodiment, the present invention is a fixation device including a median zone having a substantially triangular shape; a first fixation zone including first and second tabs that, in a separated configuration, extend away from each other from an end of the median zone, the first fixation zone having a first region adjacent the median zone and a second region adjacent the first region. Also, within the first region of the first fixation zone, an inner surface of each of the first and second tabs of the first fixation zone extends outwardly and proximally from the median zone to a first point to form an arch, and from the first point, the inner surface of each of the first and second tabs extends toward a second point. Further, within the second region of the first fixation zone, the inner surface of each of the first and second tabs of the first fixation zone extends outwardly from each second point to a respective third point so that the inner surface of each of the first and second tabs from the second point to the third point is arcuate and convex.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 13/896,894, filed May 17, 2013, which is a continuation of U.S. application Ser. No. 11/911,405, filed Mar. 17, 2008, which is a US national phase of PCT Publication PCT/FR2006/050345, filed 12 Apr. 2006, published 19 Oct. 2006 as WO2006/109004, and claiming the priority of PCT patent application PCT/FR2006/050345 itself filed 12 Apr. 2006, whose entire disclosures are herewith incorporated by reference.

FIELD OF THE INVENTION

The invention relates to the technical field of orthopaedic implants, particularly for arthrodesis and osteosyntheses.

It may be recalled that the object of an arthrodesis is to obtain very good stability both primary and secondary, and to place, or to maintain, in compression, two bone parts or bone fragments that should be consolidated. Stability is a critical factor for obtaining consolidation, while minimizing the attendant problems such as pain, swelling, etc. The compressive action serves to consolidate the osteotomy more rapidly in the position selected by the surgeon during the operation.

Various technical solutions have been proposed for carrying out an arthrodesis, particularly in the foot, the hand, the wrist, etc. Mention can be made, for example, of basic staples without shape memory which do not produce a compression, as opposed to memory staples which serve to place the two bone parts to be consolidated in compression, which corresponds to the objective.

However, to obtain satisfactory stability, it is necessary to place two, or even three staples, in different planes. This increases the dimensions considerably, thereby limiting applications (metacarpo-phalangeal joint, for example).

Extramedullary plates and screws have also been proposed, requiring an alternatively large dimension. In this respect, their miniaturization is difficult to conceive, because this could raise problems of strength and stiffness. Some types of screws can be used in intramedullary osteosynthesis, but they raise positioning difficulties (passage through the pad in particular).

Use can also be made of pins which have a smaller size. However, the stability obtained is unsatisfactory and it is necessary to withdraw them.

Intramedullary nails are also known, but they require supplementary stapling in order to prevent the bone parts to be joined from rotating relative to each other.

OBJECT OF THE INVENTION

It is the object of the invention to remedy these drawbacks simply, safely, effectively and efficiently.

The problem that the invention proposes to solve is to permit the fixation of two bone parts to one another, rigidly with dynamic and retentive compression, in order to obtain a reliable and rapid osteosynthesis.

SUMMARY OF THE INVENTION

To solve such a problem, an intramedullary arthrodesis element has been designed and developed which consists of a body with an elongated shape having, in succession, from one of its ends, a fixation zone cooperating with one of the bone parts to be immobilized, a median zone suitable for withstanding shear and bending stresses, and a fixation zone in the other bone part to be immobilized, each of the fixation zones being profiled and made from a material suitable for enabling introduction into the bone parts without a finger- or toe-tip approach, followed by a fixation in the bone parts, while avoiding any rotational movement, withstanding the tensile stresses, and maintaining a compressive force.

The invention has a particularly advantageous application, which can however not be considered as limiting, for the preparation of arthrodesis in the proximal and median phalanges, for proximal interphalangeal joints and distal interphalangeal joints, in the hand or foot.

To solve the problem of taking account of the anatomy, and particularly of the internal shrinkage of the bone, the median zone is linked to at least one of the fixation zones by a connecting zone.

To solve the problem of permitting implantation of the element followed by compression of the bone fragments, the fixation zones are made from a shape-memory material to be deformed by thermal and/or mechanical action.

To produce the fixation zones, which may be identical or not, various technical solutions are feasible, according in particular to the type of arthrodesis performed and the joints to be treated.

For example:

one of the fixation zones has two tabs or wings separable under the action of the shape memory;

one of the fixation zones has a tab or rod which can be curved under the action of the shape memory;

one of the fixation zones has, in its thickness, a slot for permitting deformation by elasticity, or memory, under the action of the shape memory.

In one embodiment, the overall body has a flat cross-section.

BRIEF DESCRIPTION OF THE DRAWING

The invention is described below in greater detail in conjunction with the figures of the drawings appended hereto in which:

FIG. 1 is a schematic plan view showing the placement of the intramedullary arthrodesis element of the invention between a proximal phalange and a median phalange to consolidate the proximal interphalangeal joint;

FIG. 2 is a plan view of an embodiment of the arthrodesis element at the time of its introduction;

FIG. 3 is a view corresponding to FIG. 2 showing the arthrodesis element after its implant to produce the compression;

FIG. 4 shows the placement of the element of the invention in a toe.

SPECIFIC DESCRIPTION

The arthrodesis element of the invention consists of an elongated body 1. Each of the ends of the body 1 is conformed to produce a fixation zone 1 a linked to a fixation zone 1 b.

Between the two fixation zones 1 a and 1 b, at least one median zone 1 c is formed capable of withstanding shear and bending stresses. In general, the shear and bending stresses are applied to the bone site to be consolidated. The shape of this median zone 1 c is adapted to the internal shape of the bone. Its length is determined in order to allow a slight offset in the centering.

For information, and in a non-limiting manner, this median zone may have a rectangular cross-section measuring about 2 to 3 mm*1 to 1.5 mm and a length of about 3 to 5 mm for the foot and the hand.

The fixation zones 1 a and 1 b are conformed to prevent any rotational movement, resist tension, and maintain manual compression applied at the time of the implant by the surgeon in order to reduce the site. To obtain this result, the fixation zones 1 a and 1 b are made from a shape-memory material to be deformed by thermal action (tepid memory) or mechanical action (superelasticity) (see U.S. Pat. No. 5,958,159). The goal, in the fixation zones, considering their profile on the one hand and the type of material on the other, is to permit an introduction into the bone parts, particularly dorsally without a finger- or toe-tip approach, on the one hand, and to produce a fixation in the bone portion in order to obtain or to maintain the desired compressive force, on the other. The fixation zones 1 a and 1 b are identical or not, according to the type of bone and its morphology.

Depending on the type of arthrodesis performed, that is, the type of interphalangeal joint to be consolidated for example, the fixation zones 1 a and 1 b may have different embodiments.

For example, one of the fixation zones 1 a has two tabs or wings that are separable under a thermal action for example. Otherwise, these fixation zones 1 a may have a single tab or rod which can be curved under the action of a memory of the component material. Otherwise, the fixation zone 1 b has, in its thickness, a slot to permit deformation by elasticity, under thermal action for example, and to maintain the position by pressing on the length of the bone.

According to another feature of the invention, to take account of the anatomy of the various phalanges for example, that is the internal shrinkage of the bone (hourglass shape), the median zone 1 c is linked to at least one of the fixation zones 1 b by a thinner connecting zone 1 d.

Reference can be made to the figures of the drawings which show an embodiment of an intramedullar arthrodesis element.

In this embodiment, the body 1 has, at one of its ends, a fixation zone 1 a in the form of two tabs or wings 1 a 1 1 a 2. This fixation zone 1 a is prolonged by a median zone 1 c of generally substantially triangular shape in a plan view. The median zone 1 c is connected to the other end fixation zone 1 b by a connecting zone 1 d having a generally rectangular shape in a plan view. The fixation zone 1 b has, in its thickness, a slot of generally oblong shape 1 b 1.

Reference can be made to FIG. 2 which shows the element at the time of its introduction, that is before separation of the tabs 1 a 1 and 1 a 2, and the opening of the slot 1 b 1. For example, this configuration is obtained when the overall element is subject to a temperature much lower than that of the human body for example. Conversely, after implantation (FIG. 3), under the effect of body heat, the tabs 1 a 1 and 1 a 2 separate, in the same way as the slot 1 b 1, concomitantly causing a deformation of the fixation zone 1 b.

It should be noted that the profile of the median zone 1 c prevents penetration when the site is reclosed.

In an alternative embodiment, the connecting zone 1 d can be split to benefit from a swelling effect by shape memory and strengthening of the anchoring in the diaphyseal zone.

It should be recalled that the inventive element is ideal for the treatment of the hammer- or claw-toe syndrome, by performing an arthrodesis in the phalanges P1 and P2 on the radii 2 to 5, while observing that such applications must not be considered as limiting, by means of essentially dimensional adjustments (finger reimplants, arthrodesis of the distal interphalangeal joint and of the proximal interphalangeal joint of the hand, and the arthrodesis of the big toe).

Obviously, the entire arthrodesis element of the invention may have constructive features suitable for improving the fixation and compression in particular.

For example:

notches on the tabs on one of the sides for better fixation in the ethmoid bone;

wavy tabs implanted (straight before implant)

to permit shortening and hence an additional compression of the arthrodesis site compared with a simple fixation;

a tapered central zone to avoid undesirable

penetration of the implant at the time when the site is to be closed.

For information, the memory used is preferably a tepid memory, so that heating is unnecessary because of the lack of access. The opening begins at above 15 to 20° C. and stops at about 30 to 35° C.

The operating technique remains conventional. 

1.-20. (canceled)
 21. A fixation device comprising: a median zone having a substantially triangular shape; a first fixation zone including first and second tabs that, in a separated configuration, extend away from each other from an end of the median zone, the first fixation zone having a first region adjacent the median zone and a second region adjacent the first region; wherein, within the first region of the first fixation zone, an inner surface of each of the first and second tabs of the first fixation zone extends outwardly and proximally from the median zone to a first point to form an arch, and from the first point, the inner surface of each of the first and second tabs extends toward a second point, and within the second region of the first fixation zone, the inner surface of each of the first and second tabs of the first fixation zone extends outwardly from each second point to a respective third point so that the inner surface of each of the first and second tabs from the second point to the third point is arcuate and convex.
 22. The device of claim 21, wherein each tab in a first fixation zone includes at least one outwardly projecting barb adapted to engage bone, the barb including a decline toward the distal end of the fixation device.
 23. The device of claim 21, further comprising a generally rectangular connecting zone adjacent the median zone.
 24. The device of claim 21, further comprising a second fixation zone including first and second tabs extending outwardly in a proximal direction away from a distal tip.
 25. The device of claim 24, wherein the second fixation zone is positioned at one end of the median zone and the first fixation zone is positioned at an opposite end of the median zone, wherein both the first and second tabs of the second fixation zone and the first and second tabs of the first fixation zone extend proximally.
 26. The device of claim 21, wherein the first and second tabs of the first fixation zone comprise a first width in the separated position.
 27. The device of claim 26, wherein the first and second tabs of the first fixation zone comprise a second width in an implantable position that is narrower than this first width.
 28. The device of claim 24, wherein the first and second tabs of the second fixation zone have a first width in an open position.
 29. The device of claim 28, wherein the first and second tabs of the second fixation zone have a second width in an implantable position that is narrower than the first width.
 30. A fixation device comprising: a body extending between a proximal end and a distal end including a proximal fixation zone, a distal fixation zone and a median zone positioned between the proximal and distal fixation zones, the proximal fixation zone including a first tab and a second tab that, in a separated zone, extend from a proximal end of the median zone in a radially outward direction, wherein an inner surface of the first and second tabs forms an arch extending from adjacent the median zone to a first point on each of the first and second tabs, forms a length along each of the first and second tabs with a decreasing slope from the first point to a second point, and forms a length along each of the first and second tabs with an increasing slope from the second point to a third point.
 31. The device of claim 30, wherein the decreasing slope from the first point to the second point defines a concave surface.
 32. The device of claim 30, wherein the increasing slope from the second point to the third point defines a convex surface.
 33. The device of claim 30, wherein the inner surface of each of the first and second tabs extends past the third point to form an apex of each of the first and second tabs and to a barb positioned on an outer surface of each of the first and second tabs.
 34. The device of claim 30, wherein the distal fixation zone includes a first tab and a second tab extending in a radially outward direction from a distal-most end towards the median zone.
 35. The device of claim 34, wherein the first and second tabs of the proximal fixation zone and the first and second tabs of the distal fixation zone both extend radially outwards in a proximal direction.
 36. The device of claim 35, further comprising a generally rectangular connecting zone positioned between the median zone and the distal fixation zone.
 37. A fixation device comprising: a body extending between a proximal end and a distal end including a proximal fixation zone, a distal fixation zone and a median zone positioned between the proximal and distal fixation zones, the proximal fixation zone including a first tab and a second tab, the first and second tabs each having a first region adjacent a second region, wherein the proximal fixation zone has an open position, in the open position an inner surface of the first region of the first and second tabs forms a convex surface and an inner surface of the second region of the first and second tabs forms a concave surface.
 38. The fixation device of claim 37, wherein the proximal fixation zone has an implantable position, in the implantable position the inner surface of the second region of the first and second tabs is substantially linear.
 39. The fixation device of claim 37, wherein the convex surface is proximal to the concave surface.
 40. The fixation device of claim 37, wherein the inner surface of the first region of the first and second tabs forms an arch. 